TPLC - Total Product Life Cycle

• Device: system, test, automated blood grouping and antibody
• Product Code: KSZ
• Regulation Number: 864.9175
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIO RAD MEDICAL DIAGNOSTICS GMBH
	SUBSTANTIALLY EQUIVALENT	2
BIO-RAD MEDICAL DIAGNOSTICS GMBH
	SUBSTANTIALLY EQUIVALENT	10
DIAGNOSTIC GRIFOLS, S. A.
	SUBSTANTIALLY EQUIVALENT	13
IMMUCOR, INC.
	SUBSTANTIALLY EQUIVALENT	14
MICRO TYPING SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	2
ORTHO-CLINICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	6
STRATEC BIOMEDICAL UK LIMITED
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	686	686
2019	298	301
2020	75	142
2021	76	213
2022	78	156
2023	120	142

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	673	941
Incorrect, Inadequate or Imprecise Result or Readings	280	318
False Positive Result	234	260
Adverse Event Without Identified Device or Use Problem	61	61
Incorrect Or Inadequate Test Results	40	40
Defective Component	27	27
Defective Device	22	22
Improper or Incorrect Procedure or Method	22	22
Computer Software Problem	13	13
Device Operates Differently Than Expected	11	11
Device Displays Incorrect Message	7	7
Inaccurate Information	7	7
Inadequate Instructions for Healthcare Professional	6	6
Non Reproducible Results	5	13
Alarm Not Visible	4	4
Leak/Splash	3	3
Device Alarm System	3	3
Patient-Device Incompatibility	3	3
Naturally Worn	3	3
Insufficient Information	3	3
Data Problem	3	3
Component Missing	3	3
Sparking	2	2
Incorrect Device Or Component Shipped	2	2
Output Problem	2	2
Patient Data Problem	2	2
Missing Test Results	2	2
Smoking	2	2
Failure to Power Up	2	2
Electrical /Electronic Property Problem	2	2
Incorrect Measurement	2	2
Mechanical Problem	2	4
Break	2	2
Circuit Failure	1	1
Coagulation in Device or Device Ingredient	1	1
Image Display Error/Artifact	1	1
Excess Flow or Over-Infusion	1	1
Contamination	1	1
Use of Incorrect Control/Treatment Settings	1	1
Cross Reactivity	1	1
Positioning Failure	1	1
Display Difficult to Read	1	1
No Display/Image	1	1
Display or Visual Feedback Problem	1	1
Nonstandard Device	1	1
Occlusion Within Device	1	1
Device Emits Odor	1	1
Power Conditioning Problem	1	1
Device Expiration Issue	1	1
Device Maintenance Issue	1	1
Product Quality Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Failure to Read Input Signal	1	1
Inadequate or Insufficient Training	1	1
Use of Device Problem	1	1
Noise, Audible	1	1
Physical Resistance/Sticking	1	1
Unintended Electrical Shock	1	1
Device Handling Problem	1	1
Failure to Clean Adequately	1	1
Misassembly During Maintenance/Repair	1	1
Protective Measures Problem	1	1
Scratched Material	1	1
Therapeutic or Diagnostic Output Failure	1	1
Maintenance Does Not Comply To Manufacturers Recommendations	1	1
Material Twisted/Bent	1	1
Failure to Deliver	1	1
Failure to Obtain Sample	1	1
Fail-Safe Problem	1	1
Failure of Device to Self-Test	1	1
Device Contamination with Chemical or Other Material	1	1
Improper Chemical Reaction	1	1
Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	841	857
No Clinical Signs, Symptoms or Conditions	263	383
No Consequences Or Impact To Patient	80	80
Test Result	32	39
Insufficient Information	24	188
No Information	19	19
Reaction	19	19
Patient Problem/Medical Problem	13	13
No Code Available	12	12
No Patient Involvement	9	9
Fever	8	8
Injury	5	5
Jaundice	4	4
Laceration(s)	3	3
Hemolysis	3	3
Hemorrhage/Bleeding	2	2
Electric Shock	2	2
Hematuria	1	1
Chemical Exposure	1	1
Alteration In Body Temperature	1	1
Unspecified Tissue Injury	1	1
Reaction to Medicinal Component of Device	1	1
Hyperbilirubinemia	1	1
Hypoxia	1	1
Bone Fracture(s)	1	1
Hearing Loss	1	1
Airway Obstruction	1	1
Exposure to Body Fluids	1	1
Overdose	1	1
Pneumonia	1	1
Rash	1	1
Respiratory Distress	1	1
Tachycardia	1	1
Chills	1	1
Anxiety	1	1